THEOPHYLLINE ANHYDROUS- theophylline tablet, extended release

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

THEOPHYLLINE ANHYDROUS (UNII: 0I55128JYK) (THEOPHYLLINE ANHYDROUS - UNII:0I55128JYK)

Saatavilla:

Bryant Ranch Prepack

INN (Kansainvälinen yleisnimi):

THEOPHYLLINE ANHYDROUS

Koostumus:

THEOPHYLLINE ANHYDROUS 400 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Theophylline is indicated for the treatment of the symptoms and reversible airflow obstruction associated with chronic asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis. Theophylline (anhydrous) extended-release tablets are contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product.

Tuoteyhteenveto:

Product: 63629-7169 NDC: 63629-7169-1 30 TABLET, EXTENDED RELEASE in a BOTTLE

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

THEOPHYLLINE ANHYDROUS- THEOPHYLLINE TABLET, EXTENDED RELEASE
BRYANT RANCH PREPACK
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THEOPHYLLINE (ANHYDROUS) EXTENDED-RELEASE TABLETS
400 MG AND 600 MG
RX ONLY
DESCRIPTION
Theophylline (Anhydrous) Extended-Release Tablets, in a
controlled-release system, allow a 24-hour
dosing interval for appropriate patients.
Theophylline is structurally classified as a methylxanthine. It occurs
as a white, odorless, crystalline
powder with a bitter taste. Anhydrous theophylline has the chemical
name 1H-Purine-2,6-dione, 3,7-
dihydro-1,3-dimethyl-, and is represented by the following structural
formula:
The molecular formula of anhydrous theophylline is C H N O with a
molecular weight of 180.17.
Each extended-release tablet for oral administration contains 400 or
600 mg of anhydrous theophylline.
Inactive Ingredients: cetostearyl alcohol, hydroxyethyl cellulose,
magnesium stearate, povidone, and
talc.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Theophylline has two distinct actions in the airways of patients with
reversible obstruction; smooth
muscle relaxation (i.e., bronchodilation) and suppression of the
response of the airways to stimuli (i.e.,
non-bronchodilator prophylactic effects). While the mechanisms of
action of theophylline are not
known with certainty, studies in animals suggest that
bronchodilatation is mediated by the inhibition of
two isozymes of phosphodiesterase (PDE III and, to a lesser extent,
PDE IV) while non-bronchodilator
prophylactic actions are probably mediated through one or more
different molecular mechanisms, that
do not involve inhibition of PDE III or antagonism of adenosine
receptors. Some of the adverse effects
associated with theophylline appear to be mediated by inhibition of
PDE III (e.g., hypotension,
tachycardia, headache, and emesis) and adenosine receptor antagonism
(e.g., alterations in cerebral
blood flow).
Theophylline increases the force of contraction of diaphragmatic
muscles. This action appears to be
due to enhancement of calcium uptake through an adenosine-mediated
channe